BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4854860 · Received June 18, 2015

    Report

    Report Number
    2032227-2015-19445
    Event Type
    Injury
    Date Received
    June 18, 2015
    Date of Event
    May 27, 2015
    Report Date
    May 27, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED AND REPORTED SHE EXPERIENCING HIGH BLOOD GLUCOSE OF 30 MMOL/L AND KETONES. CUSTOMER DID NOT BELIEVE THE INSULIN PUMP WAS WORKING ANYMORE AS CUSTOMER WAS TREATING WITH BOLUS, WHICH WAS BRINGING BLOOD GLUCOSE DOWN, BUT BASAL RATES DID NOT SEEM TO BE KEEPING BLOOD GLUCOSE DOWN. TROUBLESHOOTING WAS PERFORMED. CUSTOMER HAD RECEIVED NO DELIVERY ALARMS SINCE HIGH BLOOD GLUCOSE BEGAN. THE CUSTOMER COULD NOT COMPLETE THE HIGH PRESSURE TEST AND DECLINED TO CHECK FOR OTHER ISSUES. CUSTOMER WAS ADVISED TO CHANGE ENTIRE SET, RESERVOIR, AND INSULIN. CUSTOMER WAS ADVISED THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396368 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-715LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1